Extensive Clinical Experience

In addition to global commercial sales, NanoPass’ NanoPass’s MicronJetTM technology has already been used to administer over 27,000 injections to approximately 5,700 patients in more than 55 clinical trials, some still ongoing. The studies, conducted on subjects ranging in age from 6-week-old infants to 95 years in North America, Europe, Israel, Hong Kong, Brazil, Bangladesh and Japan, represent one of the industry’s most comprehensive database on intradermal delivery.
Intradermal vaccine delivery has been repeatedly shown to allow significant dose sparing when compared to conventional administration methods such as intramuscular and subcutaneous administration. The dermis and epidermis of the human skin are rich in antigen-presenting cells, such as Langerhans cells and dendritic cells, which play a critical role in the induction of immune responses. Injection of vaccines into these layers delivers antigens closer to these cells thus smaller doses of antigen might induce an equivalent immune response to the standard dose*.
*Darin Zehrung et al. Intradermal delivery for vaccine dose sparing: Overview of current issues. Vaccine 31 (2013) 3392– 3395

Validated Benefits

MicronJetTM has demonstrated significant dose sparing with various vaccines with down to 4% of the original dose1-8,10. It is also the first intradermal device to demonstrate dose sparing in pandemic flu4.
MicronJetTM has demonstrated a superior immune response to full dose Fluzone® intramuscular5 and improved immunogenicity to full-dose ZostaVax® and overall trend for superiority with lower doses8.

Published Studies

# Field Value analysis Reference
1 Seasonal Influenza (Fluarix) Dose sparing Van Damme P, et al. Safety and efficacy of a novel microneedle device for dose sparing intradermal influenza vaccination in healthy adults. Vaccine 2009; 27:454-9
2 Seasonal Influenza (Fluvirin) Dose sparing & Superior immunogenicity Della Cioppa G, et al. A dose-range study in older adults to compare the safety and immunogenicity profiles of MF59 adjuvanted and non-adjuvanted seasonal influenza vaccines following intradermal and intramuscular administration. Human Vaccines & Immunotherapeutics 2014; 10:6, 1-10.
3 Seasonal Influenza (Inflexal) Dose sparing & Superior immunogenicity Levin Y, Kochba E, Kenney R. Clinical evaluation of a novel microneedle device for intradermal delivery of an influenza vaccine: Are all delivery methods the same? Vaccine 2014; 34:4249-52;
4 Pandemic Influenza (H1N1) Dose sparing Hung IF, et al. Quantitative and qualitative analysis of antibody response after dose sparing intradermal 2009 H1N1 vaccination. Vaccine 30 (2012) 2707– 2708
5 Seasonal Influenza (Fluzone) Dose sparing & superior immunogenicity Hung IF, et al. Dose sparing intradermal trivalent influenza (2010/2011) vaccination overcomes reduced immunogenicity of the 2009 H1N1 strain. Vaccine 2012; 30:6427-35;
6 Polio Dose sparing Stephanie B. Troy, et al. Comparison of the Immunogenicity of Various Booster Doses of Inactivated Polio Vaccine Delivered Intradermally Versus Intramuscularly to HIV-Infected Adults. J Infect Dis. (2015) 211 (12): 1969-1976
7 Polio Dose sparing Anand A, et al. Early priming with inactivated poliovirus vaccine (IPV) andintradermal fractional dose IPV administered by a microneedledevice: A randomized controlled trial. Vaccine 33 (2015) 6816–6822
8 Zoster Dose sparing & superior immunogenicity; improved memory Chan R Beals, et al. Immune response and reactogenicity of intradermal administration versus subcutaneous administration of varicella-zoster virus vaccine: an exploratory, randomised, partly blinded trial. Lancet Infect Dis; vol 16, no. 8, p 915-922, 2016
9 PPD Painlessness Lee HJ, et al. Safety and efficacy of tuberculin skin testing with microneedle MicronJet600 in healthy adults Int J Tuberc Lung Dis 20(4):500–504 Q 2016
10 Seasonal Influenza (inflexal) Dose sparing, superior immunogenicity & adjuvant sparing Yotam Levin et.al. A phase 1, open-label, randomized study to compare the immunogenicity and safety of different administration routes and dosesof virosomal influenza vaccine in elderly. Vaccine 34 (2016) 5262–5272
11 Insulin Improved kinetics Kochba E et.al Improved Insulin Pharmacokinetics Using a Novel Microneedle Device for Intradermal Delivery in Patients with Type 2 Diabetes. Diabetes Technology & Therapeutics 2016; 18(9)
12 Intradermal delivery Review of 7 years of clinical experience with the MicronJet600 Levin Y et al Intradermal vaccination using the novel microneedle device MicronJet600: Past, present, and future. Human Vaccines & Immunotherapeutics 11:4, 991–997; April 2015;
13 Pandemic influenza (H5N1) Improved breadth of protection Carter D. et al. The adjuvant GLA-AF enhances human intradermal vaccine responses. Science Advances 12 Sep 2018: Vol. 4, no. 9, eaas9930

Ongoing Clinical Studies (Disclosed)

Field Design Phase NCT
Allergy immunotherapy
A Phase 1, Randomized, Placebo Controlled Study to Evaluate Safety, Tolerability and Immune Response in Adults Allergic to Peanut After Receiving Intradermal or Intramuscular Administration of ASP0892 (ARA LAMP Vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine I 02851277
Cancer immunotherapy This is A Phase 1 multi-center study to evaluate the clinical safety and immune response of ID-LV305 when injected intradermally in patients with advanced cancer. I 02122861
This is An open-label Phase 2 randomized study that will examine the use of the study agents, CMB305 (sequentially administered LV305 [a dendritic cell-targeting viral vector expressing the NY-ESO-1 gene] and G305 [NY-ESO-1 recombinant protein plus GLA-SE]) in combination with atezolizumab or atezolizumab alone, in patients with locally advanced, relapsed or metastatic sarcoma (synovial or myxoid/round cell liposarcoma) expressing the NY-ESO-1 protein. II 02609984
This is A Phase 1b, open label, multi-center study of CMB305 (sequentially administered LV305 [a dendritic cell-targeting viral vector expressing the NY-ESO-1 gene] and G305 [NY-ESO-1 recombinant protein plus GLA-SE]) in patients with melanoma, sarcoma, ovarian cancer, or non-small cell lung cancer that express NY-ESO-1. Ib 02387125
Varicella Zoster Vaccine Efficacy and Safety of a Novel Intradermal Live-attenuated Varicella Zoster Vaccine in Hematopoietic Stem Cell Transplantation Donors: a Randomized Double Blind Placebo-controlled Trial I 02329457
Occult Hepatitis B Prospective double-blind randomized controlled trial is to evaluate the effect and safety of topical treatment with imiquimod immediately before intradermal vaccination with Sci-B-Vac™ in patients with OBI. Our a priori hypothesis is that imiquimod pretreatment would improve immune responses to Sci-B-Vac™ further in OBI patients, resulting in HBsAb conversion. Thereby preventing subsequent complications including flare of hepatitis, cirrhosis and HCC in these patients. II/III 03307902
T1DM immunotherapy Enhanced Epidermal Antigen Specific Immunotherapy Trial -1 (EE-ASI-1): A Phase 1a Study of Gold Nanoparticles Administered Intradermally by Microneedles to Deliver Immunotherapy with a Proinsulin Derived Peptide in Type 1 Diabetes I 02837094
Pandemic influenza Safety and Immunogenicity of Inactivated Influenza A/H5N1 Vaccine Administered With or Without Topical Aldara I 03472976
Auto-immune/auto-inflammatory Double blind, placebo controlled, double-dummy study, comparing the pain perception, PK, PD, immunogenicity and tolerability of adalimumab administered SC vs. ID via microneedles in healthy adult volunteers. I/II 03607903